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Elisabeth Lieschke

Process Manager DSP MSAT Commercial

Elisabeth Lieschke
Ulm, Germany

Experience

Ulm, Germany

Process Manager DSP MSAT Commercial

  • document review, change control, and CPV
  • Product Quality Review
Ulm, Germany

Project Manager

  • revision of product information texts (labelling)
  • management and maintenance of document management systems
  • performing batch record reviews
  • performing product quality reviews
Ulm, Germany

Biopharmaceutical Quality Assurance Specialist

  • Change Control
  • Batch Record Review
  • Site RA
Ulm, Germany

Regulatory Affairs Specialist

  • dossier life cycle management, CMC and labelling
  • batch record review
  • dossier module 2.3 and 3
  • change control

Summary

Experienced regulatory affairs specialist focused on lifecycle management and pharmaceutical quality assurance in the pharmaceutical and biopharmaceutical industry

Skills

  • Communication

  • Detail-oriented Approach

  • Analytical Thinking

  • Problem-solving Skills

  • Adaptability And Ability To Prioritize

  • Flexible

  • Coordination, Creation, And Processing Of Change Control Requests

  • Review Of Dossiers (Module 2.3 And Module 3)

  • Creation Of Variation Notifications

  • Revision Of Product Information Texts (Labelling)

  • Management And Maintenance Of Document Management Systems

  • Performing Batch Record Reviews

  • Performing Product Quality Reviews

  • Document Review

  • Product Quality Review

  • Batch Record Review

  • Cmc

  • Dossier Module 2.3 And 3

  • Change Control

  • Ms Office

  • Veeva Vault

  • Webcenter Esko

  • Sharepoint

  • Trackwise

  • Sap

  • Master Control

Languages

German
Native
English
Intermediate

Education

M.D.R.A. · Drug Regulatory Affairs

Bachelor · Pharmaceutical Technology

Profile

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Elisabeth based?

Elisabeth is based in Ulm, Germany and prefers 100% remote projects.

What languages does Elisabeth speak?

Elisabeth speaks the following languages: German (Native), English (Intermediate).

What roles would Elisabeth be best suited for?

Based on recent experience, Elisabeth would be well-suited for roles such as: Process Manager DSP MSAT Commercial, Project Manager, Biopharmaceutical Quality Assurance Specialist.

What is Elisabeth's latest experience?

Elisabeth's most recent position is Process Manager DSP MSAT Commercial.

What is Elisabeth's education?

Elisabeth holds a Master in Drug Regulatory Affairs and a Bachelor in Pharmaceutical Technology.

What is the availability of Elisabeth?

Elisabeth is immediately available full-time for suitable projects.

What is the rate of Elisabeth?

Elisabeth's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.

How to hire Elisabeth?

To hire Elisabeth, click the Meet button on the profile to request a meeting and discuss your project needs.

Average rates for similar positions

Rates are based on recent contracts and do not include FRATCH margin.

1200
900
600
300
Market avg: 850-1010 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.